臨床研究等提出・公開システム

Scientific Title	Mass Balance Study of NS-229 in Healthy Adult Males (Phase I) (NS229-P1-03)
Public Title	Mass Balance Study of NS-229 in Healthy Adult Males (Phase I) (NS229-P1-03)

Contact for Scientific Queries	Name	Higashioka Masaya
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp
Contact for Public Queries	Name	Clinical Development Operations
	Affiliation	Nippon Shinyaku Co., Ltd.
	Address	14, Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto
	Telephone	+81-120-40-8930
	E-mail	zz_mail_clinical-trials@po.nippon-shinyaku.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Dec. 19, 2024
Actual date of first enrollment		Dec. 23, 2024
Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1) Provided written informed consent 2) Japanese male subjects 3) Body mass index (BMI) >=18.5 and <25.0 kg/m2 at the time of screening tests and hospitalization
	Exclusion Criteria	1) Subjects with active systemic infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, opportunistic infections) 2) Medically problematic values of activated partial thromboplastin time (APTT) or prothrombin timeinternational normalized ratio (PT-INR) at screening 3) Subjects with a history of blood disease
	Age Minimum	20age old over
	Age Maximum	40age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Healthy volunteer
Intervention(s)		[14C]NS-229 will be orally administered in single dose.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetics and safety of NS-229
Secondary Outcome(s)

Primary Sponsor	Nippon Shinyaku Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hakata Clinic Institutional Review Board
Address	6-18, Tenyamachi, Hakata-ku, Fukuoka 812-0025, Japan, Fukuoka
Telephone	+81-92-283-7701
E-Mail	miyako-koga@lta-med.com
Approval Status	Approval
Date of approval	Nov. 28, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history